Transanal endoscopic microsurgery for rectal cancer. Long-term oncologic results.

PURPOSE: Local excision of malignant rectal tumors remains controversial due to the lack of prospective studies. The principal aim of this paper is to analyze survival and recurrence of patients with rectal cancer who were operated by transanal endoscopic microsurgery with curative intention. METHODS: In 1997, we started a prospective protocol for patients who had T1/T2 rectal tumors: transanal local full-thickness excision was considered curative in T1 low risk (group A); patients with T1 high-risk and T2 low-risk tumors received postoperative radiotherapy (group B). From 1997 to 2006, 88 patients were enrolled. Sixty eight entered the study after the preoperative workup and 20 patients with an initial diagnosis of adenoma after postoperative definitive pathological assessment. RESULTS: After definitive histological findings, 54 patients were to group A, 28 to group B, and 6 had immediate radical surgery. One patient was lost for follow-up. At a mean follow-up of 71 months, 7 (4 from group A and 3 from group B) out of 81 patients recurred. Five-year overall survival was of 94% and cancer-specific survival of 96%. CONCLUSIONS: Our data support that transanal endoscopic microsurgery is an adequate treatment for T1 low-risk tumor, and no additional measures are required. For T2 low-risk lesions, our study showed a higher local recurrence rate than that reported after radical surgery but a similar survival outcome.

Local full-thickness excision as first line treatment for sessile rectal adenomas: long-term results.

OBJECTIVE: Removing rectal adenomas not only relieves symptoms, but also eradicates the incidence of carcinoma. There are many techniques for local removal of rectal polyps. Transanal endoscopic microsurgery (TEM) is the most recent. The purpose of this study is to present our long-term results using TEM for rectal adenomas, paying special attention to the risk factors of harboring a malignancy. METHODS: Data from all patients undergoing TEM from December 1995 to December 2005 were collected prospectively. The selection criteria were benign sessile adenomas below the peritoneal reflection. In the study period, 173 patients were operated on for an apparently benign rectal adenoma. The mean distance of lower tumor was 7.6 cm (range, 1-18 cm), and the mean distance to upper edge was 11 cm (2-20 cm). Full-thickness local excision was performed in all procedures. Patients were followed for a minimum of 1 year. RESULTS: According to the histologic findings, 14% of the specimens were invasive carcinomas. No statistical differences were found when comparing the histologic findings by tumor size, distance to the anal verge, or location.In 10 (5.8%) cases, the dissection was considered uncompleted because of a normal mucosa margin smaller than 1 mm. The mean hospital stay was 4 days (2-30 days). The morbidity rate was 14.5%. There was 1 postoperative death (0.6%). There were 9 (5.4%) histologically proven recurrences. Four of the patients with recurrence had uncompleted microscopic circumferential resection (P = 0.001). At a mean follow-up of 35 months (range, 12-82 months), all carcinoma patients were alive with no evidence of disease. CONCLUSIONS: In conclusion, a significant number of adenomas that we assumed preoperatively to be benign were already carcinomas and we were unable to find any reliable predictor to identify them. TEM full-thickness excision provided a low rate of postoperative morbidity and potentially avoided a significant number of major abdominal operations and local recurrences.

Efficacy of orgotein in prevention of late side effects of pelvic irradiation: a randomized study.

PURPOSE: To study whether orgotein is effective in preventing late radiation-induced effects. METHODS AND MATERIALS: Patients >18 years old who were diagnosed with rectal cancer, had an indication for pelvic irradiation (RT) after surgery, and complied with the selection criteria were randomly assigned at the end of RT to receive orgotein for 7 weeks or no treatment (control). The Radiation Therapy Oncology Group toxicity scale was used to evaluate the RT-induced side effects for up to 2 years. Interruptions due to toxicity, concomitant medication, and non-RT adverse events were also recorded. RESULTS: A total of 100 patients were included, with 50 in each group. The groups were comparable in terms of the demographic and baseline characteristics. The orgotein group had statistically significant less late toxicity than the control group (p = 0.036) and nontreated patients had a 66% greater chance of developing late toxicity at 2 years. Grouping toxicity as nonrelevant (Radiation Therapy Oncology Group Grade 0-1) and relevant (Grade 2 or worse), patients given orgotein had a lower incidence of late relevant toxicity than did controls, with statistical significance reached at all follow-up visits. After 2 years, patients not treated with orgotein had, in general, a 37% greater chance of developing late relevant toxicity; this risk was 26% when referring specifically to GI toxicity. No adverse events attributable to orgotein were recorded at any time during the study. CONCLUSION: Orgotein is a safe treatment that significantly prevents the overall occurrence of late toxicity, with toxicity reduction particularly evident in the lower GI tract.

Postoperative radiochemotherapy in rectal cancer comparison of two combination schemes: alternating versus concomitant.

AIMS AND BACKGROUND: To compare the results on disease control and toxicity of two different schedules of adjuvant combined treatment in advanced rectal cancer. METHODS: From January 1995 to September 1998, 127 patients with stage B2-C rectal cancer were treated with postoperative chemotherapy and radiotherapy with two different schemes: three cycles of 5-fluorouracil and leucovorin followed by pelvic radiotherapy and three weeks after radiation therapy was completed, another three cycles of chemotherapy were administered (alternating arm), or two cycles of 5-fluorouracil and leucovorin followed by concurrent radiochemotherapy and three weeks after ending another two cycles of 5-fluorouracil and leucovorin were administered (concomitant arm). RESULTS: Grade 3 acute toxicity was more frequent in the concomitant schedule group (33% vs 13%, P = 0.014). In the alternating schedule group, the acute adverse effects were observed after an average radiation dose of 28.4 Gy and in the concomitant schedule group after an average dose of 22.7 Gy (P = 0.012). In the arm of concomitant treatment, 37.8% of patients had to interrupt the irradiation for severe toxicity compared to 10.4% in the arm of alternating treatment (P = 0.001). There was no difference in the rate of late toxicity. The actuarial overall survival rates at 3 and 5 years were, respectively, 68.8% and 56.6% in the alternating arm and 75.5% and 61.8% in the concomitant arm (P = 0.4599). There were no differences between the two arms in the 5-year actuarial rates of overall recurrence (47% vs 51.3%, P = 0.722), local recurrence (34.6% vs 35.7%, P = 0.935) or distant recurrence (32.7% vs 31.8%, P = 0.983). CONCLUSIONS: For patients with B2-C rectal cancer, postoperative treatment with an alternating scheme of chemoradiotherapy is as effective as a concomitant scheme in control of the disease. The concomitant scheme had a higher incidence, earlier appearance and higher severity of intestinal acute toxicity than the alternating scheme, with a lower completion rate of chemoradiotherapy but without any influence on late toxicity incidence.

The efficacy of orgotein in the treatment of acute toxicity due to radiotherapy on head and neck tumors.

AIMS AND BACKGROUND: To assess the efficacy of orgotein in the treatment of acute secondary effects of radiotherapy on head and neck tumors. MATERIAL AND METHODS: Data were collected on 41 patients who received radiotherapy for tumors of the head and neck. Radiotherapy was the exclusive treatment in 19.5% of cases, with surgery in 24.4%, chemotherapy in 48.8%, and with both in 7.3%. The toxicity requiring use of orgotein was: oropharynx mucositis (26.8%), dysphagia (34.2%), or both (39%), in grade 2 or more according to the RTOG scale. Orgotein (8 mg i.m.) was administered every 48 hrs until radiotherapy was finished. RESULTS: The overall response rate was 92.5%; a complete response was obtained in 12 patients (30%) and partial in 25 (62.5%). The reduction in toxicity at the end of radiotherapy was one grade in 18 patients (45%), 2 grades in 16 (40%), 3 in 2 patients (5%), and 4 grades in the only patient with grade 4 acute toxicity. A statistically significant influence was shown in obtaining complete response: laryngeal tumor location (P = 0.037), duration of radiotherapy of more than 53 days (P = 0.002), discontinuation for non-toxic reasons (P = 0.008). CONCLUSIONS: We consider that orgotein is highly effective in dealing with acute secondary effects of radiotherapy on the head and neck area.